Evidence map›Paper›PMID 36372364›Full record

ArticleInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2023

Effectiveness and safety of bedaquiline-based, modified all-oral 9-11-month treatment regimen for rifampicin-resistant tuberculosis in Vietnam.

Thi Mai Phuong Nguyen, Thi Hai Minh Le, Corinne Simone Collette Merle, Debora Pedrazzoli, Nhat Linh Nguyen, Tom Decroo, Binh Hoa Nguyen, Thi Thanh Thuy Hoang, Viet Nhung Nguyen

Open access · goldAbstract read
In one paragraph

Article in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 4 pooled it
2.2field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 4 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
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  15. Safety and Effectiveness of 3 Novel All-Oral Shortened Regimens for Rifampicin- or Multidrug-Resistant Tuberculosis in Kazakhstan.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Article
  16. Metabolites fromMolecules (Basel, Switzerland) · 2024
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 3 countries.

Thi Mai Phuong NguyenNational Lung Hospital, Hanoi, Vietnam. Electronic address: phuongnguyen1186@gmail.com.
Thi Hai Minh LeNational Lung Hospital, Hanoi, Vietnam.
Corinne Simone Collette MerleThe Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, Geneva, Switzerland.
Debora PedrazzoliGlobal Tuberculosis Programme, World Health Organization, Geneva, Switzerland.
Nhat Linh NguyenGlobal Tuberculosis Programme, World Health Organization, Geneva, Switzerland.
Tom DecrooInstitute of Tropical Medicine Antwerp, Antwerp, Belgium.
Binh Hoa NguyenNational Lung Hospital, Hanoi, Vietnam.
Thi Thanh Thuy HoangNational Lung Hospital, Hanoi, Vietnam.
Viet Nhung NguyenNational Lung Hospital, Hanoi, Vietnam.
Hanoi Lung Hospital · VNWorld Health Organization · CHInstituut voor Tropische Geneeskunde · BE

Funding

World Health Organization 001
6 · The paper itself

Abstract

objectivesWorld Health Organization recommends a 7-drug 9-11-month rifampicin-resistant tuberculosis (RR-TB) short treatment regimen (STR). To reduce the pill burden, we assessed the safety and effectiveness of a 5-drug 9-11-month modified STR (mSTR).

methodsProspective cohort study of an all-oral mSTR (comprising bedaquiline, levofloxacin, linezolid [LZD], clofazimine, and/or pyrazinamide) for patients with RR-TB without confirmed fluoroquinolone resistance, enrolled in Vietnam between 2020-2021.

resultsA total of 108 patients were enrolled in this study. Overall, 63 of 74 (85%) achieved culture conversion at 2 months. Of 106 evaluated, 95 (90%) were successfully treated, six (6%) were lost-to-follow-up, one (1%) died, and four (4%) had treatment failure, including three with permanent regimen change owing to adverse events (AE) and one with culture reversion. Of 108, 32 (30%) patients encountered at least one AE. Of 45 AEs recorded, 13 (29%) were serious (hospitalization, life threatening, or death). The median time to AE was 3 months (IQR: 2-5). A total of 26 AEs led to regimen adaptation: either dose reduction (N = 1), drug temporary interruption (N = 19), or drug permanent discontinuation (N = 6, 4 attributed to LZD).

conclusionThe high treatment success of 5-drug mSTR might replace the 7-drug regimen in routine care. AEs were frequent, but manageable in most patients. Active AEs monitoring is essential, particularly when using LZD throughout.

Indexed as

Antitubercular AgentsTuberculosis, Multidrug-ResistantDiarylquinolinesHumansLinezolidProspective StudiesRifampinVietnamAntitubercular AgentsbedaquilineDiarylquinolinesLinezolidRifampinAll-oral regimenBedaquilineDrug-resistant tuberculosisShorter regimen

Identifiers

PMID36372364
PMCPMC9789925
OpenAlexW4308928968

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.